Efficacy and Safety of Faster-acting Insulin Aspart compared to NovoRapid® both in Combination with Insulin Degludec in Children and Adolescents with Type 1 Diabetes

Phase 1

• Conditions: Diabetes Mellitus, Type 1; MedDRA version: 19.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2014-002568-33-EE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-10
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

1. Male or female, 1 = age < 18 years at the time of signing informed consent and < 18 years at the time of randomisation
2. Diagnosed with type 1 diabetes mellitus (based on clinical judgement and supported by laboratory analysis as per local guidelines)
3. Ongoing daily treatment with a basal-bolus insulin regimen using basal insulin analogue or NPH insulin for at least 90 days prior to the screening visit
4. HbA1c = 9.5% (80 mmol/mol) analysed by the central laboratory at the screening visit

Are the trial subjects under 18? yes
Number of subjects for this age range: 750
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. More than one episode of diabetic ketoacidosis requiring hospitalisation within the last 90 days prior to the screening visit
2. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified